Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

Brief Summary

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Background:

Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.

Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.

It is, however, possible to perform the operation without the use of the tourniquet.

Aim and hypothesis:

The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.

Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.

H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.

Methods:

80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.

The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied

Impact of the project:

The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Non-tourniquet assisted TKA

Group Type EXPERIMENTAL

Non-tourniquet assisted TKA

Intervention Type PROCEDURE

The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.

Tourniquet assisted TKA

Group Type OTHER

Tourniquet assisted TKA

Intervention Type PROCEDURE

The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.

Interventions

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Non-tourniquet assisted TKA

The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.

Intervention Type PROCEDURE

Tourniquet assisted TKA

The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
* Patients who can tolerate spinal anesthesia

Exclusion Criteria

* Patients with rheumatoid arthritis.
* Patients with BMI \> 35.
* History of major knee operations.
* Malignancy.
* Known muscle disease.
* History of deep vain thrombosis (DVT), or other blood coagulation disorders.
* Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No